NEBIDO 1000MG/4ML SOLUTION FOR INJECTION

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Package leaflet: Information for the user

Nebido
1000 mg/4 ml, solution for injection
Testosterone undecanoate

What is in this leaflet
1. What Nebido is and what it is used for
2. What you need to know before you are given Nebido
3. How to use Nebido
4. Possible side effects
5. How to store Nebido
6. Contents of the pack and other information

1. What Nebido is and what it is used for
Nebido contains testosterone, a male hormone, as the active
ingredient. Nebido is injected into a muscle in your body.
There it can be stored and gradually released over a period
of time. Nebido is used in adult men for testosterone
replacement to treat various health problems caused by a
lack of testosterone (male hypogonadism). These should be
confirmed by two separate blood testosterone
measurements and also include clinical symptoms such as:
R impotence
R infertility
R low sex drive
R tiredness
R depressive moods
R bone loss caused by low hormone levels

2. What you need to know before you are
given Nebido
Do NOT use Nebido
R if you are allergic to testosterone undecanoate or any of
the other ingredients of this medicine (listed in
section 6)
R if you have androgen-dependent cancer or suspected
cancer of the prostate or of the breast
R if you have or had a liver tumour
Nebido is not intended for use in women.
Nebido is not for use in children and adolescents. There is
no data available on the use of Nebido in males under 18
years of age.

Warnings and precautions
Talk to your doctor before using Nebido if you have or have
ever had:
R epilepsy
R heart, kidney or liver problems
R migraine
R temporary interruptions in your breathing during sleep
(apnoea), as these may get worse
R cancer, as the level of calcium in your blood may need to
be tested regularly
R blood clotting problems
R high blood pressure or if you are treated for high blood
pressure, as testosterone may cause a rise in blood
pressure.
If you are suffering from severe heart, liver or kidney
disease, treatment with Nebido may cause severe
complications in the form of water retention in your body
sometimes accompanied by (congestive) heart failure.
The following blood checks should be carried out by your
doctor before and during the treatment: testosterone blood
level, full blood count.
If your liver is not working
No formal studies have been performed in patients with
liver impairment. You will not be prescribed Nebido if you
have ever had a liver tumour (see “Do not use Nebido”).
Elderly patients (65 years or older)
There is no need for your doctor to adjust the dose if you are
over 65 (see “Medical examination/follow up”).
Muscle building and drug tests
Nebido is not suitable for building muscles in healthy
individuals or for increasing physical strength.
Nebido might lead to positive results in drug tests.
Medical examination/Follow-up
Male hormones may increase the growth of prostate cancer
and enlarged prostate glands (benign prostatic
hypertrophy). Before your doctor injects Nebido, he/she will
examine you to check that you do not have prostate cancer.
Your doctor will regularly examine your prostate and breast,
especially if you are elderly. He/she will also take regular
blood samples.
Following the use of hormonal substances such as androgen
compounds, cases of benign (non-cancerous) and malignant
(cancerous) liver tumours have been observed to occur.
Other medicines and Nebido
Tell your doctor or pharmacist if you are using or have
recently used or might use any other medicines, including
medicines obtained without a prescription. The doctor may
need to adjust the dose if you are using any of the following:
R the hormone ACTH or corticosteroids (used to treat
various conditions such as rheumatism, arthritis,
allergic conditions and asthma): Nebido may increase


The following information is intended for healthcare
professionals only:
The solution for intramuscular injection is to be
visually inspected prior to use and only clear
solutions free from particles should be used.
The contents of an ampoule / vial are to be injected
intramuscularly immediately after opening the
ampoule / vial.
The medicinal product is for single use only and any
unused solution should be discarded.
Administration
Special care must be given to avoid intravasal
injection.
As with all oily solutions, Nebido must be injected
strictly intramuscularly and very slowly. Pulmonary
microembolism of oily solutions can in rare cases

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3. How to use Nebido
Your doctor will inject Nebido (1 ampoule / vial) very slowly
into a muscle. He/she will give you the injections every 10 to
14 weeks. This is enough to maintain sufficient testosterone
levels without leading to a build-up of testosterone in the
blood.
Nebido is strictly for intramuscular injection. Special care
will be taken to avoid injection into a blood vessel (see
“Notes on handling the OPC (One-Point-Cut) ampoule”).
Start of treatment
Your doctor will measure your blood testosterone levels
before starting treatment and during the early stages of
treatment. Your doctor may give you the second injection
after only six weeks in order to quickly reach the necessary
testosterone level. This will depend on your symptoms and
testosterone levels.
Maintaining your Nebido levels during treatment
The injection interval should always be within the
recommended range of 10 to 14 weeks.
Your doctor will measure your testosterone levels regularly
at the end of an injection interval to make sure it is at the
right level. If the level is too low, your doctor may decide to
give you injections more often. If your testosterone levels
are high, your doctor may decide to give you injections less
often. Do not miss your injection appointments. Otherwise,
your optimum level of testosterone will not be maintained.
If you think that the effect of Nebido is too strong or too
weak, talk to your doctor.
If you use more Nebido than you should
Symptoms of having too much Nebido include:
R irritability
R nervousness



Read all of this leaflet carefully before you are given
this medicine because it contains important
information for you.
R Keep this leaflet. You may need to read it again.
R If you have any further questions, ask your doctor.
R This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
R If you get any side effects, talk to your doctor. This
includes any possible side effects not listed in this
leaflet. See section 4.

the risk of water retention, especially if your heart and
liver are not working properly
R blood-thinning tablets (coumarin derived oral
anticoagulants) since this can increase the risk of
bleeding. Your doctor will check the dose.
R medicines used to treat diabetes. It may be necessary to
adjust the dose of your blood sugar reducing medicine.
Like other androgens, testosterone may increase the
effect of insulin.
Please be sure to inform your doctor if you suffer from a
disturbance of blood clotting, because this is important
for your doctor to know before deciding to inject Nebido.
Nebido may also affect the results of some laboratory tests
(e.g. thyroid gland). Tell your doctor or the laboratory staff
that you are using Nebido.
Pregnancy and breast-feeding
Nebido is not for use in women and must not be used in
pregnant or breast-feeding women.
Fertility
Treatment with high doses of testosterone preparations
commonly may reversibly stop or reduce sperm
production (see also under “Possible side effects”).
Driving and using machines
Nebido has no observed effect on your ability to drive or use
machines.

lead to signs and symptoms such as cough,
dyspnoea, malaise, hyperhidrosis, chest pain,
dizziness, paraesthesia, or syncope. These reactions
may occur during or immediately after the injection
and are reversible. Treatment is usually supportive,
e.g. by administration of supplemental oxygen.
Suspected anaphylactic reactions after Nebido
injection have been reported.
Warnings
Careful and regular monitoring of the prostate
gland and breast must be performed in accordance
with recommended methods (digital rectal
examination and estimation of serum PSA) in
patients receiving testosterone therapy at least
once yearly and twice yearly in elderly patients and
at risk patients (those with clinical or familial
factors).

Besides laboratory tests of the testosterone
concentrations in patients on long-term androgen
therapy the following laboratory parameters
should be checked periodically: haemoglobin,
haematocrit, and liver function tests and lipid profile.
In patients suffering from severe cardiac, hepatic or renal
insufficiency or ischaemic heart disease, treatment with
testosterone may cause severe complications characterised
by oedema with or without congestive cardiac failure. In
such case, treatment must be stopped immediately.

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4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
The most common side effects are acne and pain where
the injection is given.
Common side effects (may affect up to 1 in 10 patients):
R abnormally high levels of red blood cells
R weight gain
R hot flushes
R acne
R enlarged prostate and associated problems
R various reactions where the injection was given (e.g.
pain, bruising, or irritation)
Uncommon side effects (may affect up to 1 in
100 patients):
R allergic reaction
R increased appetite, changes in blood test results (e.g.
increased blood sugars or fats)
R depression, emotional disorder, insomnia, restlessness,
aggression, or irritability
R headache, migraine, or tremor
R cardiovascular disorder, high blood pressure, or
dizziness
R bronchitis, sinusitis, cough, shortness of breath,
snoring, or voice problems
R diarrhoea, or nausea
R changes in liver test results
R hair loss, or various skin reactions (e.g. itching,
reddening, or dry skin)
R joint pain, pain in limbs, muscle problems (e.g. spasm,
pain or stiffness), or an increased creatine
phosphokinase in the blood
R urinary tract disorders (e.g. decreased flow of urine,
urinary retention, urge to pass urine at night)
R prostatic disorders (e.g. prostatic intraepithelial
neoplasia, or hardening or inflammation of the
prostate), changes in sexual appetite, painful testicles,
painful, hardened or enlarged breasts, or increased
levels of male and female hormones
R tiredness, general feeling of weakness, excessive
sweating, or night sweats
Rare side effects (may affect up to 1 in 1000 patients):
R The oily liquid Nebido may reach the lungs (pulmonary
microembolism of oily solutions) which can in rare cases
lead to signs and symptoms such as cough, shortness of
breath, feeling generally unwell, excessive sweating,
chest pain, dizziness, “pins and needles”, or fainting.
These reactions may occur during or immediately after
the injection and are reversible.

Suspected anaphylactic reactions after Nebido injection
have been reported.
In addition to the side effects listed above the following
have been reported following treatment with preparations
containing testosterone: nervousness, hostility, brief
interruptions in breathing during sleep, various skin
reactions including dandruff and oily skin, increased hair
growth, more frequent erections, and very rare cases of
yellowing of the skin and eyes (jaundice).
Treatment with high doses of testosterone preparations
commonly stops or reduces sperm production, although this
returns to normal after treatment ceases. Testosterone
replacement therapy of poorly functioning testicles
(hypogonadism) can in rare cases cause persistent, painful
erections (priapism). High-dosed or long-term
administration of testosterone occasionally increases the
occurrences of water retention and oedema (swelling due to
fluid retention).
For testosterone products in general a common risk of
increased red blood cell count, haematocrit (percentage of
red blood cells in blood) and haemoglobin (the component
of red blood cells that carries oxygen), were observed by
periodic blood tests.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the
Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Nebido
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage
conditions.
Do not use this medicine after the expiry date which is
stated on the carton and the label after “EXP”. The expiry
date refers to the last day of that month.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help to
protect the environment.

R weight gain
R long-lasting or frequent erections
Tell your doctor, if you have any of these. Your doctor will
inject it less often or will stop treatment.


Notes on handling the OPC (One-PointCut) ampoule:
There is a pre-scored mark beneath the
coloured point on the ampoule eliminating
the need to file the neck. Prior to opening,
ensure that any solution in the upper part of
the ampoule flows down to the lower part.
Use both hands to open; while holding
the lower part of the ampoule in one hand,
use the other hand to break off the upper
part of the ampoule in the direction away
from the coloured point.

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Notes on handling the vial
The vial is for single use only. The content of
a vial is to be injected intramuscularly
immediately after drawing up into the
syringe. After removal of the plastic cap (A)
do not remove the metal ring (B) or the
crimp cap (C).